Application for Registration of Pharmaceutical Manufacturer from Overseas
Procedure Name
Application for Registration of Pharmaceutical Manufacturer from Overseas
Description
Description
According to the Law on Pharmaceutical Management and Law on Amendment of Law on Pharmaceutical Management, Cambodian citizens of either sex or foreigner have the right and may apply for permission from the Ministry of Health to open manufacturing establishments and pharmaceutical importers in Cambodia.
Having a license to open pharmaceutical manufacturing and exporting pharmaceutical companies is a prerequisite for obtaining the right to trade in medicines, such as importing or exporting wholesale stocks to legal pharmacies of all kinds of medicines and vaccines (serums, vaccines). For the health sector, including medical and dental equipment such as material, equipment, instrument, implement, appliance, apparatus, implant, machine, disinfectant, in vitro reagent and calibrator, and software that serves the health sector. Whereas foreign pharmaceutical companies must also pre-register before obtaining permission to import their pharmaceutical products for distribution in the Cambodian market.
Medicines and vaccines, as well as medical and dental equipment that is allowed to be imported and exported, must first be registered.In the same way, for the trade, export, and import of cosmetic products, it is necessary to have a license to open cosmetics import store and to register the cosmetic products to be imported and exported first.
This document shows the procedure for applying for a certificate of registration of a pharmaceutical company abroad.
Place for submitting application
The One Window Service “OWSO” is located in the Ministry and has officials from specialized departments such as the Department of Medicine, Food, Medical Equipment, and Cosmetics on duty to provide services related to their units. Applicants can also contact the specialized department located in the same Ministry.Department of Medicine, Food, Medical Equipment, and Cosmetics The Ministry of Health
Address: Office of the Ministry of Health, Lot 80, Samdech Pen Nuth Street (289), Sangkat Boeung Kak II, Khan Toul Kork, Phnom Penh
Applicants can contact the OWSO to request a sample application. In some cases where there is no official at the OWSO, applicants can contact the Department of Drugs, Food, Medical Equipment, and Cosmetics directly for sample application or through the website: Department of Drugs and Food (ddfcambodia.com)
Note 2
Applicants may appoint a representative to apply but must have a power of attorney or letter of introduction.Attachments for applying for registration of these overseas pharmaceutical companies include:
Pharmacist certification recognized by the Ministry of Health
Resume of the applicant (sample
Health certificate issued by the Ministry or Department of Health
A letter of conviction issued by the Ministry of Justice
At least 5 office and warehouse location diagrams
3 photos of the person concerned
Note 3
The implementation of internal procedures is started from the specialized office and goes through a number of hierarchies as defined in the law. Prior to reaching a decision, the specialist officer may contact the applicant directly for any necessary supplementation required for the adequacy of the request, such as requiring the applicant to provide additional documents to the expert officer.
Note 4
After issuing the approval decision on the application, the professional officer will contact the applicant to pay the service fee. The service fee is 1.2 million Riels for the issuance of a new institution license, which is valid for 2 years, and for the application for renewal, the Ministry sets the service fee at 70% of the original service fee.
Note 5
There are some cases where the applicant is told to get the license directly from the department. Applicants should bring their ID card or other identification along with their receipt/payment receipt.
Drug Import companies and representative offices shall firstly be registered for pharmaceutical manufacturing just being approved to be registered of Drug productions in the Ministry of Health.
To ensure good manufacturing practice in drug production and to ensure that the drug productions are of high quality agreeing to the international standards
Drug export companies shall firstly be registered of pharmaceutical manufacturers just being approved to be registered of Drug productions in the Ministry of Health.
To receive the correct information provided by pharmaceutical manufacturers about the good manufacturing practice situation in drug production to ensure that the drug productions are high quality agreeing to the international standard.
